FDA Tells At-Home Diagnostics Companies To Stop Coronavirus Test Roll-Outs
Four different diagnostics companies were planning to ship at-home tests for the coronavirus infections to their customers this week, but are instead “pausing” their roll-outs in order to avoid the displeasure of Food and Drug Administration (FDA) bureaucrats. In fact, companies are destroying samples sent back from customers rather than testing them to comply with FDA guidance.
The companies had launched their tests based on their interpretation of the latest FDA Emergency Use Authorization (EUA), which says that any lab that had been certified under the appropriate quality-control standards could start performing coronavirus tests. They were all using just such labs.
For example, to comply with the FDA’s testing guidance TechCrunc
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